BG Medicine said that it has jointly designed the project, called the Liver Toxicology Biomarker Study, with the FDA "with input from a number of pharmaceutical companies." The company said that the study will be funded by pharmaceutical manufacturers, who will receive "a paid-up perpetual license to any biomarkers discovered and access to all project data."
The LTBS will be conducted at the FDA's NCTR laboratory in
BG Medicine said it expects the project to result in improved tests for liver toxicity, which is the most common biological reason for drug failure in the development of new drugs. Current toxicity testing methods "often fail to identify human liver toxicity issues," the company said. "Consequently, liver toxicity is often detected for the first time when drugs are in phase 2 of clinical testing after tens of millions of dollars or more have been spent on a drug."